The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.
Pictured: Pfizer sign in front of building/courtesy JHVEPhoto/GettyImages
The FDA has approved Pfizer’s nasal spray, zavegepant, now to be marketed as Zavzpret, for the acute treatment of migraine in adults, the company announced Friday.
Zavzpret is a small molecule antagonist of the calcitonin gene-related peptide (CGRP) receptor, which is an emerging target for acute migraine relief, particularly for patients who have contraindications or poor response to triptan-based medications. Zavzpret is the first CGRP antagonist nasal spray for migraine with or without aura.
Data from two pivotal Phase III trials supported Zavzpret’s FDA bid, both of which showed significantly better efficacy relative to placebo. Pfizer’s nasal spray induced statistically higher rates of pain freedom – defined as a decrease in headache pain from moderate-to-severe to none – and freedom from the most bothersome symptom two hours after dosing.
A Phase III study published in The Lancet Neurology also showed that Zavzpret significantly outperformed placebo in the majority of secondary endpoints, including early pain relief, return to normal function and durability of effect.
Zavzpret was well-tolerated, and the most common side effects included taste disorders, nausea, nasal discomfort and vomiting. Zavzpret is contraindicated for patients who had previously shown hypersensitivity to zavegepant and its components.
Zavzpret’s approval gives people with migraine an alternative option to oral medications, Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said in a statement. The company will continue to build its migraine business moving forward.
An oral formulation of zavegepant is also in Phase II for migraine prevention.
Bounty from the Biohaven Buyout
Friday’s FDA approval of Zavzpret underscores Pfizer’s decision to ink one of biopharma’s largest deals in history.
Pfizer first gained rights to Zavzpret in May 2022, when it dropped $11.6 billion to acquire leading migraine player Biohaven. Under the terms of the agreement, Pfizer bought all of Biohaven’s outstanding shares and paid all of its third-party debt.
All told, the acquisition price was a 33% premium to Biohaven’s volume-weighted average selling price over the prior three months.
At the time of the acquisition, Pfizer already had close ties with Biohaven and owned a 2.6% stake in the company. The two also had a commercialization partnership over zavegepant, which they entered into in January 2022.
Aside from Zavzpret, the Biohaven buyout brought Nurtec ODT (rimegepant) into Pfizer’s fold. The drug, approved in February 2020 for the prevention of acute and episodic migraine in adults, won Pfizer $213 million in revenue in 2022, the vast majority of which was made in the U.S.
The assets that Pfizer earned from the Biohaven buyout were strong growth drivers in the fourth quarter of 2022.
